Introduction: Hemodialysis treatment requires anticoagulation to prevent thrombosis of the dialyzer. The Hydrolink (R) (NV series; Toray) has been designed to reduce thrombotic complications by increasing membrane hydrophilic properties. Previous studies have confirmed reduced platelet activation, improved removal of beta 2-microglobulin and excellent small-solute removal.Methods: We designed a prospective, multi-centered, randomized clinical study to compare the antithrombogenic effects (platelet count) of NV dialyzers versus conventional treatment. To compare the possibility of performing heparin-free dialysis, we carried out progressive heparin reduction tests. Patients with an average platelet count lower than 170,000 cells/mm(3) using standard high flux membranes in the 6 months prior to the study were enrolled and randomized. Patients were either dialyzed for 6 months without changing the previous membrane (control group) or treated with the Hydrolink (R) membrane (NV group). After the third week, the heparin reduction test was conducted for 5 weeks in order to assess the minimum amount of anticoagulant needed to safely perform a 4-hour dialysis treatment. Performance and safety were evaluated measuring platelet count and activation, middle-molecule removal rate and nutritional status.Results: We found no significant difference in platelet count, platelet activation factors beta-thromboglobulin and platelet factor 4 (PF-4), between the groups. More patients in the study group reached heparin-free dialysis without clotting events during the heparin reduction test. The NV dialyzers displayed anti-thrombogenic effects as compared to conventional dialyzers.Conclusions: The NV dialyzer series is safe with no adverse events reported. Further studies are required to understand the mechanisms of anti-thrombogenic effects.

Prospective, Randomized, Multicenter, Controlled Trial (TRIATHRON 1) on a New Antithrombogenic Hydrophilic Dialysis Membrane / Ronco, Claudio; Brendolan, Alessandra; Nalesso, Federico; Zanella, Monica; De Cal, Massimo; Corradi, Valentina; Virzì, Grazia M; Ferrari, Fiorenza; Garzotto, Francesco; Lorenzin, Anna; Karopadi, Aakash N; Sartori, Marco; De Rosa, Silvia; Samoni, Sara; Husain-Syed, Faeq; Spinelli, Alessandra; Neri, Mauro; Villa, Gianluca; Alghisi, Alberta. - In: INTERNATIONAL JOURNAL OF ARTIFICIAL ORGANS. - ISSN 0391-3988. - 40:5(2017), pp. 234-239. [10.5301/ijao.5000608]

Prospective, Randomized, Multicenter, Controlled Trial (TRIATHRON 1) on a New Antithrombogenic Hydrophilic Dialysis Membrane

De Rosa, Silvia;
2017-01-01

Abstract

Introduction: Hemodialysis treatment requires anticoagulation to prevent thrombosis of the dialyzer. The Hydrolink (R) (NV series; Toray) has been designed to reduce thrombotic complications by increasing membrane hydrophilic properties. Previous studies have confirmed reduced platelet activation, improved removal of beta 2-microglobulin and excellent small-solute removal.Methods: We designed a prospective, multi-centered, randomized clinical study to compare the antithrombogenic effects (platelet count) of NV dialyzers versus conventional treatment. To compare the possibility of performing heparin-free dialysis, we carried out progressive heparin reduction tests. Patients with an average platelet count lower than 170,000 cells/mm(3) using standard high flux membranes in the 6 months prior to the study were enrolled and randomized. Patients were either dialyzed for 6 months without changing the previous membrane (control group) or treated with the Hydrolink (R) membrane (NV group). After the third week, the heparin reduction test was conducted for 5 weeks in order to assess the minimum amount of anticoagulant needed to safely perform a 4-hour dialysis treatment. Performance and safety were evaluated measuring platelet count and activation, middle-molecule removal rate and nutritional status.Results: We found no significant difference in platelet count, platelet activation factors beta-thromboglobulin and platelet factor 4 (PF-4), between the groups. More patients in the study group reached heparin-free dialysis without clotting events during the heparin reduction test. The NV dialyzers displayed anti-thrombogenic effects as compared to conventional dialyzers.Conclusions: The NV dialyzer series is safe with no adverse events reported. Further studies are required to understand the mechanisms of anti-thrombogenic effects.
2017
5
Ronco, Claudio; Brendolan, Alessandra; Nalesso, Federico; Zanella, Monica; De Cal, Massimo; Corradi, Valentina; Virzì, Grazia M; Ferrari, Fiorenza; Garzotto, Francesco; Lorenzin, Anna; Karopadi, Aakash N; Sartori, Marco; De Rosa, Silvia; Samoni, Sara; Husain-Syed, Faeq; Spinelli, Alessandra; Neri, Mauro; Villa, Gianluca; Alghisi, Alberta
Prospective, Randomized, Multicenter, Controlled Trial (TRIATHRON 1) on a New Antithrombogenic Hydrophilic Dialysis Membrane / Ronco, Claudio; Brendolan, Alessandra; Nalesso, Federico; Zanella, Monica; De Cal, Massimo; Corradi, Valentina; Virzì, Grazia M; Ferrari, Fiorenza; Garzotto, Francesco; Lorenzin, Anna; Karopadi, Aakash N; Sartori, Marco; De Rosa, Silvia; Samoni, Sara; Husain-Syed, Faeq; Spinelli, Alessandra; Neri, Mauro; Villa, Gianluca; Alghisi, Alberta. - In: INTERNATIONAL JOURNAL OF ARTIFICIAL ORGANS. - ISSN 0391-3988. - 40:5(2017), pp. 234-239. [10.5301/ijao.5000608]
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